The patent is expected to be issued during 2014 and will have a 2029 expiry date. RHB-104 is a proprietary antibiotic combination oral capsule formulation for the treatment of Crohn’s disease, currently undergoing a Phase III study in the U.S., Canada and Israel (the MAP US study).
RedHill further noted that it has initiated a long-term population pharmacokinetic (Pop PK) study as part of the ongoing RHB-104 Phase III MAP US study.
The Pop PK study, together with other supportive studies, including a recently completed food effect study, a drug-drug interaction (DDI) study currently being reviewed and additional clinical and other studies, are designed to satisfy various regulatory requirements for future potential marketing applications of RHB-104.
In January 2014, the Company reported that it had received preliminary results from a Phase I study with RHB-104 that was designed to evaluate the effect of co-administration of food on the pharmacokinetics of the constituent components of RHB-104 and two metabolites, and the safety and tolerability of RHB-104 under fed and fasting conditions.
RedHill has since received the final Clinical Study Report (CSR) which confirms the previously announced preliminary results.
In addition to existing FDA clearance in the US, RedHill has received regulatory clearance to commence the Phase III MAP US study in Canadian and Israeli sites, and the first clinical sites in both countries have already initiated patient enrollment.
As a result, there are currently 44 clinical sites in the U.S., Canada and Israel actively enrolling patients for the RHB-104 Phase III MAP US study. RedHill has increased the total number of planned clinical sites to up to approximately 90 sites in the U.S., Canada and Israel, and is planning additional clinical sites in other countries.
RedHill has also become an official sponsor of the Crohn’s and Colitis Foundation of America ("CCFA") and is working together with the CCFA to create awareness and advance recruitment in the U.S. among the U.S. Crohn’s patient population. As more clinical sites are activated in the coming months, and sufficient clarity is obtained, RedHill aims to provide an update regarding its estimated timeline for completion of recruitment in the Phase III MAP US study.
The Phase III MAP US study is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.
RedHill is planning to commence a second Phase III study with RHB-104 for Crohn’s disease in Europe (the MAP Europe study) following successful Scientific Advice Meetings with the UK and Swedish pharmaceutical regulatory agencies and discussions with key opinion leaders in Europe.
The Company is currently in the process of selecting a contract research organization (CRO) for the MAP Europe study. Subject to receiving all the required regulatory approvals and other preparations, the MAP Europe study is planned to commence during the second half of this year.
Currently in a Phase III study for the treatment of Crohn’s disease, RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by the Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients.
The RHB-104 formulation was originally developed by Professor Thomas Borody, a leading innovator of therapeutic approaches to treating gastrointestinal tract diseases, who also developed the original triple therapy for peptic ulcer disease associated with H. pylori. Several clinical trials were conducted with earlier formulations of the drug, including an Australian Phase III study published by Pfizer, as well as other studies, both with earlier formulations and the current formulation of the drug. The formulation of RHB-104 is covered by several issued and pending patents.